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Completed

NCT Number: NCT00715156

Role of Recombinants in Peach Allergy

This study is aimed at verifying the role and the efficacy of the recombinants allergens Pru p 1, Pru p 3 and Pru p 4, Bet v 1, Bet v 2 and Bet v 4 in the diagnosis of peach allergy

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Niguarda Hospital

Milan, Italy, 20162

About this study

This study intend to verify whether the different levels of severity of the clinical allergic reactions to peach are associated to sensitization towards different allergenic molecules of peach. In particular, we will analyze the reactivity towards the peach allergens Pru p 1, Pru p 3 and Pru p 4 and towards the birch pollen allergens Bet v 1, Bet v 2 and Bet v 4. The patients (with allergic symptoms of any severity provoked by the consumption of peach) will be divided into two groups: the first group showing oral allergy syndrome (OAS), the second group showing systemic symptoms of different severity, up to anaphylaxis.

All the patients will be submitted to: complete clinical investigation; skin prick test with a panel of common food/inhalant commercial extracts; skin tests by the "prick + prick" method with fresh fruits and vegetables; skin prick test with purified peach LTP (Pru p 3) The sera of the patients will be used for: immunoblotting with peach extract and immunoblotting inhibition with purified natural Pru p 3 and, if possible, recombinant Pru p 3, Pru p 1 and Pru p 4, using a pool of selected sera; CAP system with a predetermined panel of fruit and vegetable allergens; CAP system with recombinant allergens of peach and birch pollen: Pru p 3, Pru p 1 and Pru p 4 for peach, Bet v 1, Bet v 2 and Bet v 4 for birch pollen. Finally, a statistical analysis will be carried out in order to verify if the two groups of patients will show significant differences in the allergens recognized. The results of this study will be a property of the Unit of Allergology and Immunology as stated by DM 17/2004 and will be presented as written publication or oral presentation at National and/or International Congresses of Allergy and Immunology, quoting the PHADIA company

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female and male;
  • pts with 18 e 80 years old;
  • signature of the informed consent form;
  • CAP/RAST positive for peach;
  • clinical manifestation of peach allergy

Exclusion criteria

  • pregnancy;
  • current antihistamine therapy;
  • subjects that do not give consent to the study

Treatment and study plan

Primary outcomes

  1. Evaluation of diagnostic efficacy of PHADIA IMMUNO-CAP with the peach recombinant allergens Pru p 3, 1 and 4 as compared to peach IMMUNO-CAP in the identification of peach allergic subjects at major risk of anaphylaxis

    Time frame: 1 year

Secondary outcomes

  1. Evaluate whether the above recombinants allergens could help identifying subjects with severe reaction to other fruits

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

Classification of Different Forms of Peach Allergy and the Role of Recombinant Allergens in the Diagnosis

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jul 15, 2008
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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